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Although fortification of expressed breast milk (EBM) via commercially available human milk fortifiers (HMF) has been shown to increase short-term weight and length among preterm very low-birth-weight (VLMW) neonates, widespread adoption of HMF is hampered by high cost and the increased risk of severe adverse events.
A prospective study from India in JAMA Pediatrics sought to determine if preterm formula powder fortification (PTF) might be a better alternative to HMF, especially in resource-limited settings.
“Adequate nutrition in the immediate postnatal period is essential for the optimal growth and development of preterm VLBW neonates,” said corresponding author M Jeeva Sankar, MD, DM, an associate professor of pediatrics at All India Institute of Medical Sciences (AIIMS) in New Delhi, India. “Exclusive breast milk feeding alone is not sufficient to meet the daily requirements of the VLBW neonates.”
Despite fortification of the mother’s milk or human donor milk being the standard of care in most neonatal intensive care units (NICUs) to achieve optimal growth in these neonates, “the commercial HMFs used for fortification are fairly expensive and are associated with severe adverse effects, including feed intolerance and late metabolic acidosis,” Sankar told Contemporary OB/GYN®.
The open-label, noninferiority, randomized study was conducted at a level 3 neonatal unit in Delhi, India, from December 2017 to June 2019.
The trial enrolled 123 preterm VLBW neonates (born at or before 34 weeks of gestation) receiving at least 100 mL/kg/d of feeds and consuming a minimum 75% of milk as EBM.
The neonates were randomly assigned to receive fortification by either PTF (n = 60) or HMF (n = 63) (the control group).
To meet the recommended dietary allowances, the PTF group was supplemented with calcium, phosphorus, iron, vitamin D and multivitamins, as opposed to only vitamin D in the HMF group.
The mean gestation (30.5 weeks for the PTF group and 29.9 weeks for the HMF group) and birth weight (1,161 g and 1,119 g, respectively) were comparable between the 2 groups.
There was also no difference in the mean daily weight gain through discharge from the hospital or 40 weeks’ postmenstrual age (whichever was earlier) between the PTF and HMF groups: 15.7 vs 16.3 g/kg/d, respectively: mean difference −0.5 g/kg/d (95% confidence interval [CI]: −1.9 to 0.7).
The lower bound of 95% CI did not cross the noninferiority margin.
However, the incidence rate of feed intolerance was lower in the PTF group than in the HMF group: 1.4 vs. 6.8 per 1,000 patient-days; incidence rate ratio 0.19 (95% CI: 0.04 to 0.95).
The PTF group also comprised fewer neonates requiring withholding of fortification for 24 hours or more: 5% vs 22%, respectively; risk ratio 0.22 (95% CI: 0.07 to 0.75).
On the other hand, the incidences of necrotizing enterocolitis stage II or higher (0% in the PTF group vs. 5% in the HMF group) and extrauterine growth restriction (defined as <10th percentile on the Fenton chart at 40 weeks’ postmenstrual age) (73% vs 81%, respectively) were similar between the two groups.
“Postnatal growth restriction in preterm newborns and subsequent malnutrition during infancy is a significant problem in low- and middle-income countries like India,” Sankar said. “Thus, we believe that fortification of breast milk with PTF may be a better option than fortification with HMF in these settings, given the similar short-term weight gain and considerable savings in the costs incurred by fortification of breastmilk.”
However, the one obstacle that investigators envision in the preparation of sachets of 1 g or less of PTF in the NICU is that “most units will not be able to weigh the exact amount of the powder that needs to be made into sachets,” Sankar said. “But this can be overcome by simple, though not fool-proof, methods like approximately dividing the contents of the scoop (5 g) into five equal parts and then making sachets.”
The money saved by embracing PFT over HMF could be redirected to strengthening the healthcare infrastructure to reduce preventable neonatal and infant deaths, according to the authors.
Sankar reports no relevant financial disclosures.
Chinnappan A, Sharma A, Agarwal R, et al. Fortification of breast milk with preterm formula powder vs human milk fortifier in preterm neonates: a randomized noninferiority trial. JAMA Pediatr. Published online May 10, 2021. doi:10.1001/jamapediatrics.2021.0678